In earlier blogs, we have written about specific technical items related to identity testing. However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]
The FDA’s Office of Pharmaceutical Quality (OPQ) is the group within the FDA that defines the quality requirements for all human drugs under its umbrella (filed as NDAs, ANDAs, BLAs, 351(k)/Biosimilars, and OTC products). The group issued its 2019 Annual Report just this month (read the full report here) that includes a look back […]
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement on Monday, February 3, 2020 (here) regarding their collaborative plans to advance competition in the biologics market. This joint effort is intended to address misinformation and anti-competitive behavior that may impede competition between biologic drug products. A significant focus […]
Today, the FDA released a guidance document titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (here). The document provides the FDA’s responses to eight questions designed to help firms assure that they do not run afoul in advertising or promotion when describing similarities and differences between the […]
The Q&A document addresses a number of frequently asked questions about the Pre-Launch Activities Importation Request (PLAIR) process, and when you can or cannot use a PLAIR for importing unapproved drug product into the United States. Quite interestingly, there are quite a few answers of “no” to the FAQs, which likely demonstrates that firms have […]
Each year at holiday time, we try to provide a little levity in some of our blog posts, as well as spread some good cheer. So here you go – love it or not – we fully expect this to be sung outside Building 31 in Bethesda on the evening of December 24th. To the […]
Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect. A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”. Since the beginning of time, the Agency […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
Dr. Scott Gottlieb is back in the private sector and took the time to give the attendees at the AAM conference a brief overview of his experience as Commissioner. Dr. Gottlieb spoke about the creation of the Competition Action Plan which addressed action on the following issues: Gaming the system through REMS and restricted distribution […]
The reinvention of the AAM’s Fall conference from The Fall Technical Conference to the GRx + Biosimilars Conference continues to be a success. This year’s meeting included a very stimulating and informative agenda pertinent to generic drugs and biosimilar products. On Monday morning, Suzette Kox, MSc, Pharm. Sec’y. Int’l. Generic and Biosimilar Medicines Association (IGBA) […]
